Category Archives: Hematology

Counties Pursue Safer Drug Disposal

New programs to make it easier and safer for San Francisco Bay Area residents to get rid of unused medications are some of the first to try this on a large scale, and may serve as models for other cities and counties.

Since May 2012, a pilot program in San Francisco has allowed residents to drop off old medications at 13 pharmacies and 10 police stations (where controlled substances must be brought). San Francisco supervisors initially considered forcing drug companies to fund the program, and instead agreed to accept $110,000 from Genentech and the Pharmaceutical Research and Manufacturers of America to fund the program.

(Photo by J. Troha, courtesy of National Cancer Institute)

On July 24, supervisors in Alameda County (which includes East Bay cities such as Oakland and Berkeley) are likely to approve a Safe Drug Disposal Ordinance that would require drug companies to pay for disposal of their products or face fines of up to $1,000 per day, The Bay Citizen reports. Public agencies currently fund 25 drug disposal sites there, and the cash-strapped county wants the comparatively wealthy pharmaceutical industry to take more financial responsibility for the lifecycle of its products in order to reduce overdoses, accidental poisonings, and water pollution.

As we reported earlier this year, making prescription-drug “recycling” a cultural norm is one of five emerging public policies that could help the medical system keep opioids available while reducing the risk of addiction, abuse and accidental overdose, according to Keith N. Humphreys, Ph.D. Smaller versions have met with success, such as a drug take-back day organized by sheriffs in a small town in Arkansas (population 20,000) that brought in 25,000 pills, said Dr. Humphreys, acting director of the Center for Health Care Evaluation, Veterans Health Administration, Menlo Park, Calif., and a professor of psychiatry at Stanford University. He reports having no financial conflicts of interest on this issue.

Not everyone is happy with the idea. Trade associations for the pharmaceutical industry and biomedical companies argue that there’s no evidence that these programs will reduce poisonings, and they haven’t ruled out the possibility of suing to block the Alameda County ordinance, The Bay Citizen reports. The compromise that San Francisco reached for voluntary instead of mandatory funding from the pharmaceutical industry may be a middle ground.

In an era when government agencies have less and less money for public programs, it’s probably inevitable that they’ll pursue alternative financing for programs like this.

If your community has a drug disposal program, let us know how it’s working. Will these programs succeed, and will they reduce abuse, addiction, and accidental overdoses? We’ll keep an eye on this topic, and keep you posted.

–Sherry Boschert (@sherryboschert on Twitter)

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Should Physicians Prescribe Positivity?

Scott Jordan Harris  is a U.K.-based blogger, editor, book author, movie critic, and sports writer. Remarkable, considering that he spends most of his time in bed. His primary diagnosis is myalgic encephalomyelitis (ME), also known as chronic fatigue syndrome.

In a piece he wrote last week for the BBC’s website, Mr. Harris said that keeping a diary in which he focuses on the positive aspects of his life — at the suggestion of a doctor – keeps him “sane.”

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“My depression told me my existence was filthy and barren…. After a few months of storing up the previously unrecorded richness of my life, my diary simply disproved that. I knew from re-reading the pages I’d written that I was doing interesting things — and I began to ensure I kept doing them simply to have something to write about. The diary was better than therapy; it pushed me forward through mental pain that had been holding me back.”

He added, “Doctors unaware of the realities of the lives of the chronically ill often suggest we waste what little energy we have noting down exactly how unwell we feel each day, how much we sleep and how little we do, so that they may study the results. These doctors are to be smiled at, and nodded to, and instantly ignored.”

So should physicians advise patients with chronic conditions to keep positive diaries?  I asked two experts.  Dr. Daniel Clauw, a rheumatologist who directs the University of Michigan’s Chronic Pain and Fatigue Research Center, referred me to his associate, Afton Hassett, Psy.D.

“That was a compelling story in the BBC and it actually does reflect my clinical and research experience as a pain psychologist,” Dr. Hassett told me.

Negative and positive affect (emotions) have been well-studied  in health in general and chronic and acute pain states in particular. There are numerous studies suggesting that positive affect plays an important role in pain outcomes. While few formal studies have evaluated the effectiveness of the exact intervention Mr. Harris described, there are studies   supporting the efficacy of similar positive psychology interventions for depression, Dr. Hassett said.

“Enhancing positive affect is likely a good thing for one’s mental and physical health. Sometimes just keeping a gratitude journal like the BBC article writer noted is all it takes. I always tell people to write down three different things each day for which you are grateful. After the first week or so you really start looking for the small wonders in your life: a great cup of coffee, a kind gesture from a complete stranger, the first tiny yellow flowers of spring.”

Courtesy Wikimedia Commons/4028mdk09/Creative Commons License

But Dr. David Spiegel, a psychiatrist who heads the Stanford University Center on Stress and Health, urges caution regarding positive psychology.   “I think the drumbeat for upbeat can be a little overwhelming… I agree with [Mr. Harris] that just focusing on how bad you feel you can dig yourself into a pit, but at the same time you can’t deny your feelings. The worst thing you can do to a depressed person is to tell them to cheer up.”

However, Dr. Spiegel, who works with breast cancer patients, noted that “you can help them by saying let’s give dimension to what’s bothering you, but also put that in perspective, and see other things that are good, that are positive. So it’s not one or the other…Happiness is not the absence of sadness.”

Dr. Spiegel said that advising patients with chronic conditions to keep a diary in general is an “interesting idea,” and that there is a literature base  for the medical benefits of journaling.

He advised that physicians suggest to their patients, “See if it helps you to have a daily journal of your journey through this illness, what your problems were and what your little victories were, and what you did that helped you deal with it and get beyond it.”

—Miriam E. Tucker (@MiriamETucker on Twitter)

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Step Aside, Pink

Courtesy Wikimedia Commons/Jason Meredith/Creative Commons

Raise your hand if you’ve never seen a pink ribbon or don’t know what it means.

No one?

The tremendous success of the pink ribbon breast cancer awareness campaign is a great fundraising and awareness lesson for any charitable organization.  There are no clear numbers on research funds raised by pink ribbons, in part because there are so many sources for pink ribbon items. Still, those ribbons and the public awareness they’ve raised have made a huge difference in breast cancer research and survival. For example, the 5-year breast cancer relative survival rate in 1975-1977 was 75%. In the most recent data from the American Cancer Society’s Cancer Statistics 2011 (table 12), the 5-year breast cancer relative survival rate in 1999-2006 was 90%.

According to the NCI Snapshot of Breast Cancer: “In the United States, breast cancer is the most common non-skin cancer and the second-leading cause of cancer-related death in women. Each year, a small number of men are also diagnosed with or die from breast cancer. Although the rate of diagnosis of breast cancer increased in the 1990s, it has decreased since 2000, and the overall breast cancer death rate has dropped steadily.” In 2008, the incidence rate for breast cancer in white women and African American women is just a tad less than 130 breast cancers per 100,000 women in each group.

The point is this: we’re had incredible success in raising money, awareness and survival for breast cancer. Maybe it’s time to put the same effort into defeating other cancers.

For example, the 5-year relative survival rate for lung/bronchus cancer — represented by a white ribbon, by the way — in 1975-1977 was 13%; in 1999-2006 that rate had increased only to 16%.  Worse still: the 5-year relative survival rate for pancreatic cancer (purple ribbon)  in 1975-1977 was 3%; in 1999-2006 that rate was 6%.

According to the NCI Snapshot of Lung Cancer, lung cancer is the second most common cancer and is the primary cause of cancer-related death in both men and women in the United States. The overall mortality rate for lung and bronchus cancers rose steadily through the 1980s and peaked around 1993. Mortality rates are highest among African-American males, followed by white males.

The button I wear to support my dad's battle against lung cancer. Kerri Wachter/Elsevier Global Medical News

In 2008, the incidence rate of lung cancer among African American men was roughly 100 per 100,000 men; for white men the rate was about 70 per 100,000 men.  Remember though that the 5-year relative lung cancer survival rate in 2006 was estimated at 16%.  That’s a lot of people dying…and that’s just lung cancer. By the way November is the awareness month for lung cancer and stomach cancer (periwinkle ribbon).

The point is, maybe it’s time that the White Ribbon (or purple or gray or … ) became the new Pink Ribbon.
Kerri Wachter

Special thanks to David Sampson, director of medical & scientific communications for the American Cancer Society, for his help with data.

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Bundled Dialysis Payments May Leave Some Shortchanged

It’s difficult not to equate the Centers for Medicare and Medicaid Services’ bundled payment system for outpatient hemodialysis with, say, handing a 12-year-old boy a $10 bill to buy lunch and telling him to keep the change.

That the 12 year old might decide to forego the healthful $9.95 veggie wrap with a side of fruit in favor of the $1 Snickers bar so he can pocket the $9 profit is well within the realm of possibility. In the same vein, should we really be surprised to learn that hemodialysis facilities might not be optimizing patient care when they are being paid a flat fee vs. separate payments for each service —  if not to make a buck, to avoid losing one? A study reported during Kidney Week 2011, the annual meeting of the American Society of Nephrology, hints at just such a scenario.

Image courtesy of Image Courtesy Wikimedia Commons/Elembis/Creative Commons

Using data from the nationally representative Dialysis Outcomes and Practice Patterns Study (DOPPS) practice monitor, investigators with the Ann Arbor Research Collaborative for Health in Michigan determined that uncontrolled secondary hyperparathyroidism has been on the rise among black hemodialysis patients since the implementation in January 2011 of the CMS’s prospective payment system for dialysis services. The system bundles payments for dialysis treatments, supplies, drugs, and lab tests. It rewards facilities for meeting or exceeding quality measures in the Medicare fee-for-service system.

Although the revised payment system is intended to “improve patient outcomes and promote efficient delivery of health care services,” in the words of CMS administrator Donald Berwick, the Ann Arbor investigators hypothesized that the increased financial constraints may lead to less use of intravenous vitamin D analogs, and thus poorer control of secondary hyperparathyroidism (SHPT). Black patients would be left especially vulnerable because they require higher vitamin D doses on average than other patients, according to lead investigator Dr. Francesca Tentori.

To test the hypothesis, the investigators examined trends in parathyroid hormone (PTH) values and SHPT in dialysis patients from July 2010-February 2011 and observed a notable increase in PTH levels overall and in severe, uncontrolled SHPT (defined as a PTH level greater than 600 pg/ml) among black patients.

Specifically, the median PTH value rose among blacks from 296 to 379 pg/ml and from 244 to 283 among non-blacks, and the prevalence of SHPT rose significantly from 16-25% among blacks and slightly, from 9-11% among nonblacks,  Dr. Tentori reported.

Based on preliminary analysis, “these changes don’t appear to be related to decreased overall use of [SHPT] treatments, as the percentage of prescribed intravenous vitamin D rose slightly in both groups, or to changes in serum calcium or phosphorous,” Dr. Tentori said. The findings warrant further evaluation to tease out the cause of the trend, particularly because untreated SHPT has been linked to increased mortality risk in dialysis patients, she stressed.

Dr. Tentori disclosed financial relationships with Amgen, Genzyme, KHK, Abbott, and Baxter.

—Diana Mahoney

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Whose Rights Are at Stake?

The Supreme Court heard arguments Tuesday in support of the 2007 Vermont statute limiting the release of the information detailing which drugs doctors prescribe. This information is maintained by pharmacies, which sell it to data-mining agencies, that in turn sell it to drug companies, for marketing purposes. Patient information is excluded from the data, doctor’s information is not.

Under the Vermont law, this information can be released only with the consent of the doctor. However, once data collection firms like IMS Health and interested parties like Pharmaceutical Research Manufacturers of America, challenged the statute, the issue became a question of free speech.

In the case of Sorrell v. IMS Health Inc., data-mining firms claim they have First Amendment rights to buy and sell the information for their marketing use.

However, the state’s attorney’s office likened the release of the confidential information to disclosing a doctor’s tax returns, patient files, or a competitor’s business information, arguing that First Amendment rights in the case apply to protecting doctor’s information. But since the information is given away to parties including insurance companies, journalists, and law enforcement, the court wasn’t too convinced.

” … just don’t tell me that the purpose is to protect their privacy,” said Justice Antonin Scalia. “[A doctor's] privacy isn’t protected by saying you can’t sell it but you can give it away.”

Justice John Roberts said Vermont is trying to reduce health care costs by “censoring” information doctors hear about brand-name drugs, with the intent that they will prescribe more generics, a measure Justice Scalia added was a restriction on free speech.

Vermont Assistant Attorney General Bridget Asay responded that “the purpose of the statute is to let doctors decide whether sales representatives will have access to this inside information” on the prescribing habits of physicians.

Attorneys general of several states, the federal government, AARP, medical associations, privacy groups, and the New England Journal of Medicine have filed briefs in support of the Vermont statute, according to a brief by Cornell (N.Y.) University Law SchoolThe National Association of Chain Drug Stores, the Association of National Advertisers, the Associated Press, and Bloomberg have filed in support of the data mining firms.

In an age in which personal data can mined through social networks and search engines, this case could set the precedent concerning how much personal information can be used for marketing. A decision is expected by June.

 Tell us what you think. 

–Frances Correa (@FMCReporting on Twitter)

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In the Developing World, Diseases Defy Definition

Before last week, I thought I knew the definition of “noncommunicable disease.” Then I attended “The Long Tail of Global Health Equity: Tackling the Endemic Non-Communicable Diseases of the Bottom Billion.”

 Held on the campus of Harvard Medical School in Boston March 2nd and 3rd, the 2-day conference was sponsored by Partners In Health, an international nonprofit organization that conducts research, does advocacy, and provides direct health care services for people living in poverty around the world. The “Bottom Billion” of the meeting’s title refers to the world’s poorest people living on less than $1 per day.

 In a 2008-2013 action plan, the World Health Organization refers to “the four noncommunicable diseases – cardiovascular diseases, diabetes, cancers and chronic respiratory diseases and the four shared risk factors – tobacco use, physical inactivity, unhealthy diets and the harmful use of alcohol.” Together, these conditions account for approximately 60% of all global deaths, of which 80% occur in low- and middle-income countries. 

A cancer patient in Rwanda receives chemotherapy as her husband and physician discuss her treatment / Photo courtesy of Partners In Health

But as I learned at the conference, among the Bottom Billion, rheumatic heart disease is often the result of an untreated streptococcal infection early in life, diabetes is frequently associated with malnutrition rather than over-nourishment, and cervical cancer due to human papillomavirus is far more common than in the developed world, where women routinely receive PAP screenings and a vaccine can now also prevent the infection.   

And most startling to me: Among the world’s poorest, smoking is not the most common cause of chronic obstructive pulmonary disease. Cooking with biomass fuels is.   

Individually, these and other so-called “endemic NCDs” including Burkitt’s lymphoma, sickle cell disease, and tropical diseases are far less common than those within the WHO’s “four-by-four” definition. But together, that “long tail” of chronic conditions contributes to a great deal of suffering. 

In May 2010, the United Nations announced that it would hold a high-level meeting on NCDs in 2011, now set for September 19-20. It will be only the 29th such meeting that the UN has ever held (formerly called “special sessions“), and just the second pertaining specifically to a health issue. The first one, the 2001 Summit on HIV/AIDS, is credited with focusing global attention and obtaining public and private funding for that cause. 

Speakers at the Partners In Health meeting stressed that the NCD movement should not be undertaken as an “us against them” competition with infectious disease for scarce resources. In a statement that will be presented to the heads of government at the UN summit, the group called instead for “strengthening and adjusting health systems to address the prevention, treatment, and care of NCDs, particularly at the primary health care level.”

—Miriam E. Tucker (@MiriamETucker on Twitter)

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Dawning of the Age of Dabigatran

Last Monday, the American College of Cardiology and the American Heart Association revised their guidelines for preventing stroke in patients with atrial fibrillation, making the new anticoagulant dabigatran an officially recommended alternative to warfarin. That action followed the FDA’s approval of dabigatran for preventing stroke in patients with atrial fibrillation (AF) last October, and the drug’s entry onto the U.S. market in early November under the trade name Pradaxa.

Image by Mitchel Zoler

Patients with AF need daily anticoagulant treatment because of their high risk that a blot clot will form in their quivering heart atrium, enter the circulation, lodge in a cerebral artery, and cause a stroke. Until now, the only anticoagulant available to try to prevent this was warfarin, effective but notoriously hard to maintain at the right dosage and requiring patients to go to an anticoagulation clinic every few weeks to have their warfarin control checked and tweaked. The entry of dabigatran onto the U.S. market and now its designation as an officially-sanctioned alternative to warfarin opens a new anticoagulant era for the growing ranks of AF patients because with dabigatran visits to an anticoagulation clinic aren’t needed.

Last week, at the International Stroke Conference, I spoke  with Dr. Margaret C. Fang, an AF specialist and director of the anticoagulation clinic at the University of California, San Francisco. Dabigatran prescriptions to AF patients are already being written by community physicians who may not have a handy warfarin clinic to refer patients to, she told me. “We’re hearing of patients in the community who are now on dabigatran who were never referred to the clinic. I think there will be a lot of enthusiasm in the community” for prescribing dabigatran. Despite directing an anticoagulation clinic that may soon become obsolete as new anticoagulants supplant warfarin, Dr. Fang said that she shared the enthusiasm “because I can see all the bad things that happen with warfarin.”

Last November, I spoke with another arrhythmia expert, Dr. Gordon F. Tomiselli, chief of cardiology at Johns Hopkins in Baltimore, who told me: “Over the course of the next year, a lot of my patients will change from warfarin. What I hear from patients now who are on warfarin is, ‘When can I start with the new drug so that I can stop the rat poison?’”

It might sound like I’m shilling for the company that makes dabigatran, but I’m not. I have no disclosures, gain nothing from this changing of the anticoagulation guard. But I am impressed by the drug’s data, and by the response it’s received from experts who deal with warfarin and with AF.  A new medical era is here. The dabigatranification of AF anticoagulation has begun.

—Mitchel Zoler (on Twitter @mitchelzoler)

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Remembering the Father of Erythropoietin

Biochemist Eugene Goldwasser, who had the drive and tenacity to spend more than 20 years isolating the first minute amounts of human erythropoietin, died at 88 last Friday, December 17. After Dr. Goldwasser and his lab staff isolated a few milligrams of the protein in 1977, he  eventually decided to collaborate with Amgen and in 1980 allowed them to start using some of his precious isolate to hunt for the gene. Amgen cloned the gene in 1985, and then began marketing the gene product as Epogen in 1989.

image courtesy of Flickr user with a hook

One of his colleagues at the University of Chicago, Dr. Donald Steiner, called Dr. Goldwasser’s isolation of erythropoietin a medical landmark similar in importance to the discovery of insulin. Although erythropoietin has gone through rocky times recently, with evidence of adverse effects curbing its use and dropping sales, the various marketed forms of  erythropoietin continued this year to tally billions of dollars in sales and substantial clinical benefits in patients with anemia.

I first learned of Dr. Goldwasser’s death in an obituary I read this morning, and subsequently I found several other pieces about him on the web. These include obits from the University of Chicago, The Chicago Tribune, The New York Times, and journalist Merrill Goozner, who wrote about Dr. Goldwasser’s work in a 2004 book on drug development. Also, a  remembrance by Dr. John Henning Schumann, a Chicago colleague and friend. Taken together, they sketch a committed, multi-faceted man motivated by a scientific challenge and a desire to help advance medical care.

For me, two nuggets from the write-ups standout. First is the vignette of of Dr. Goldwasser meeting a Japanese researcher in the lobby of Chicago’s Palmer House Hotel in 1975 to accept a modestly-sized box that inside held the dried concentrate of 2,550 liters of urine collected from patients with aplastic anemia. Over the next couple of years, Dr. Goldwasser and his associates purified from this gift a few milligrams of human erythropoietin, the first isolation of the human protein and a key step on the path toward cloning the gene and large-scale production.

Second is the poignant story of how both the University of Chicago and Dr. Goldwasser failed to patent erythropoietin, allowing Amgen to become the owner of this very valuable franchise. The University’s omission sounds like an oversight, but for Dr. Goldwasser it was a conscious decision to sidestep the fortune he could have claimed.

“Gene never profited from his discovery, the way that scientists and inventors now clamor to patent everything in sight,” wrote his friend Dr. Schumann. “He believed that his discovery should be shared with the public; after all, the government had funded his research career–he figured the taxpayers ought to get the benefit of his discovery.”

It was an act that recalls a more innocent era in biomedical research. Filing for patents “was not generally done at the time,” said his University of Chicago colleague, Dr. Gary Toback, who added, “He was someone who took enormous delight in doing science.” Soon after Dr. Goldwasser’s death his son said: “He was first and foremost a scientist and he was gratified that he was able to make such a great contribution.” For a person like that, the thrill of having his 20+ year quest fulfilled and seeing the subsequent impact erythropoietin had on clinical practice must have been payback enough.

—Mitchel Zoler (on Twitter @mitchelzoler)

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The Art of Medicine

There’s a great deal of art in the practice of medicine. It just doesn’t usually find its way into medical meetings.

Lilly Oncology On Canvas©

 Yet, there in the poster hall at the Chicago Multidisciplinary Symposium in Thoracic Oncology, amongst all the talk of TKI resistance and MEK inhibitors, were easels full of art including a pastel of mischievous fairies dancing among daisies and a painting of a bald woman smiling out from behind a pair of rose-colored spectacles beside the words, “Life is full of surprises.”  

The pieces are part of the Lilly Oncology On Canvas project, an art competition and exhibition launched in 2004 with the National Coalition for Cancer Survivorship as a way for those affected by cancer to express themselves and provide inspiration to others. The competition is open to patients, family members, friends, and caregivers and, surprisingly, health care providers.

"Best of Exhibition" 2010 Lilly Oncology On Canvas©

More than 600 entries were received for the 2010 competition, with Annette Zalewski , a nurse of nearly 30 years, earning three awards including “Best of Exhibition” for her determination to continue weaving together a beautiful life that was “cut up, rearranged” by lung cancer.
 
 This past year, previous winning pieces toured no less than 285 cancer centers, hospitals and cancer advocacy events from San Francisco and D.C. to such tiny towns as Opelousas, La., and Yankton, S.D. Some of the art and remains behind, with cancer charities also receiving up to $10,000 donated in the name of the winners.
RxArt project founder Diane Brown has decided to take the art concept one step further after a frightening CT exam left the former gallery owner and curator wishing for a diversion. Ms. Brown now coordinates with artists to place original installations in exam rooms and even splashes them across pricey diagnostic equipment. The result blows the typical hospital lobby floral landscape out of the water.
Even the stoic Scots have launched the Art in Hospitals project, which coordinates art exhibitions from the dialysis room to the psychiatric ward and offers workshops where patients can experiment creating their own art.
I can’t help but think all of this would please the 56-year-old retired physician turned pastel artist detailed in a case report just two aisles over in the poster hall from the Lilly Oncology On Canvas display.
The artist was diagnosed with squamous cell carcinoma of the lung, an uncommon pathology in a never-smoker. After four cycles of adjuvant chemotherapy, physicians at Mayo Clinic Arizona found no evidence of disease on her latest CT.
The authors note, however, that lung cancer in never-smoking women is the fastest growing subset of patients with lung cancer. Hopefully, these women’s journeys through cancer will be enriched with healthy doses of both medicine and art.

Patrice Wendling (on Twitter @pwendl)

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Not Just Kid Stuff: Reconciling Young Adults to Children’s Cancer Regimens

Some of the most advanced cancer research involves treating cancer in children. And recent studies show that some adolescents and even young adults in their 20s fare better on children’s protocols than on adult protocols.

courtesy of flickr user sean dreilinger (creative commons)

For example, in one study presented at the annual meeting of the American Society of Hematology, patients aged 16-21 years with non-M3 acute myeloid leukemia who were randomized to a Children’s Oncology Group regimen had higher overall survival rates than those who were treated with one of two adult regimens: the Cancer and Leukemia Group B regimen and the Southwest Oncology Group regimen.

To make it trickier, when the study group was broken down into younger (16-18 years) and older (19-21 years), the younger patients on the children’s protocol had significantly greater event-free survival compared to the older patients on the children’s protocol. There was no significant difference in event-free survival based on age among the patients on the adult protocols.

However, the treatment-related mortality was significantly higher in patients in the children’s protocol vs. the adults (29% vs. 7%).

How do doctors decide how to treat their teen patients? The answers aren’t clear, but as Jane MacNeil, editor of our sister publication The Oncology Report, observed, 18-year-olds might object to being treated in a children’s cancer facility full of balloons and teddy bears, even if a children’s regimen might be best for them. What is the solution? If research continues to show a benefit of treating older adolescents and young adults with children’s protocols, maybe a “young adult cancer ward” is the wave of the future. Pictures of Taylor Swift instead of Teddy Bears?

–Heidi Splete (on Twitter @hsplete)

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